Evaluating the Risk of Serious Ventricular Arrhythmia and Sudden Cardiac Death Among Users of Domperidone
The purpose of this population-based, observational study is to evaluate the combined risk
of serious ventricular arrhythmia (irregular heart rhythm) and sudden cardiac death in users
of domperidone (a medication used to treat certain gastrointestinal disorders) compared with
users of proton pump inhibitors (another group of medications used to reduce gastric or
stomach acid production. The study will be conducted using patient information from
Saskatchewan Health (SH) who had recorded dispensings of domperidone or a PPI from 1990
through 2005. The first objective of the study is to estimate the combined relative risk of
the occurance of a particular type of irregular heart rhythm known as serious ventricular
arrhythmia (SVA) and sudden cardiac death SCD (defined as a natural death from an
unexpected circulatory arrest) during current use of domperidone or current use of proton
pump inhibitors (PPIs) as compared with nonuse in a diabetic population. The second
objective is to estimate the combined relative risk of SVA and SCD during current use of
domperidone or current use of PPIs as compared with nonuse in a non-diabetic population.
Study drug dosing information not required for Observational Study
Observational
Observational Model: Case Control, Time Perspective: Retrospective
The occurance of serious ventricular arrhythmia and sudden cardiac death (combined end point)
Retrospective study
Yes
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Study Director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Institutional Review Board
CR016396
NCT00925457
December 2005
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